MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION NEUROMODULATION DEVICE; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Model Number NEU_UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problem Burning Sensation (2146)

Event Date 12/13/2021

Event Type  Injury  

Event Description

On (b)(6) 2021, information was received from the patient's daughter, via a manufacturer representative (rep), regarding a patient receiving an unknown drug via an implantable pump.The patient's daughter called and requested to speak with a nurse because the patient was having problems with their device.The caller mentioned the patient has been hospitalized for 5 days and the area around the device was burning the patient.The patient moved and lived 300 miles away from their clinician and was referred to a new manufacturer representative (rep).The caller was disconnected before additional information could be obtained.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: NEUROMODULATION DEVICE
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 13018673
• MDR Text Key: 282340679
• Report Number: 2182207-2021-02186
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NEU_UNKNOWN
• Device Catalogue Number: NEU_UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/13/2021
• Initial Date FDA Received: 12/16/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Sex: Female